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Quality Systems Leader: Becton Dickinson & Company (BD)

Lead the Quality System group responsible for the development, implementation and management of the Quality System at the Wilson Pharmaceutical facility. The Wilson quality system is compliant to 21CFR 210&211 and Becton Dickinson Corporate policies. The Quality System Leader will implement and continually improve the system(s) to enable business growth and optimize effectiveness and efficiency. This position will rely on experience and judgment in order to plan and accomplish goals.

Main Responsibilities:

o Lead the Quality System group to ensure quality system development and compliance with 21CFR 210&211, Becton Dickinson Corporate policies, and all other applicable quality / regulatory requirements. Establish quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with all applicable internal and external regulatory requirements o Consult with internal clients on the interpretation of quality system regulations, standards and associated guidance as applied to corrective actions, preventive actions, new process development, process maintenance, and quality system architecture. o Develop, implement and report on measures of local quality system effectiveness such as: Performance Scorecard, Issues reporting, CAPA, Management Review, etc. o Implementation of quality objectives and plans to ensure that all employees are involved in integrating quality into their processes to meet quality objectives o Lead the efforts for generating Annual Product Reviews o Support and develop systems for the identification, analysis, correction, and prevention of quality issues o Set and manage clear project priorities based on compliance risk assessment and business prioritization o Develop, implement and execute initiatives to improve the user experience with and compliance of the Quality system
o Manage the Document Control Group
o Manages Wilson Change Control Review Board including serving as the CCRB chair
o Manages Wilson CAPA System including serving as the CAPA board chair o Proactively develop and maintain expertise of staff on subject matter expertise of quality system regulations, standards, and corporate policies to ensure Quality System compliance o Develop and maintain department operating procedures and work instructions o Recruit, hiring and perform annual planning / performance processes o Provide performance objectives, reviews, coaching and professional development of subordinates o Performs other related duties as assigned
Required Skills and Knowledge - Bachelors degree in a scientific discipline. 5+ years of relevant Quality Assurance experience in a pharmaceutical manufacturing company. Experienced investigator. Experience with managing a change control program. Experienced/knowledgeable of pharmaceutical processing techniques such as aseptic manufacture. Excellent attention to detail and working knowledge of FDA Regulations/Guidance's, Good Manufacturing Practices, and ICH Guidelines. Maintains a safe working environment

Technical Area of Expertise - excellent verbal and written communication, organization, prioritization, displays sound judgment, problem-solving, interpersonal and analytical skills. Experience with FDA inspections. Understanding of basic statistical analysis
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